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NCT Number: NCT05974384

Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management.

Fractures of the distal end of the radius are one of the most frequent fractures diagnosed in the emergency room. The initial management, and in many cases definitive, is carried out through manipulation, closed reduction and immobilization in the emergency room. Different methods of anesthesia have been described to reduce pain during the manipulation and reduction procedure, such as: hematoma block, periosteal block, general anesthesia, intravenous regional anesthesia, nitrous oxide, intramuscular sedation, and conscious sedation. Despite the use of different methods of anesthesia, none is fully effective and each of these methods is not free of complications. Adjuvant measures could play an important role in improving the patient's experience during the procedure, however, there is little evidence in this regard.

Music is increasingly being studied and developed as an adjunctive therapy in the management of pain and anxiety in different medical procedures, demonstrating a statistically significant reduction in pain and anxiety. However, in the literature there is no evidence of studies that evaluate the effect of music during the reduction of fractures in traumatology as an adjuvant therapy for the management of pain and anxiety.

In our experience, despite the anesthesia used, reductions of distal radius fractures are usually a painful procedure that involves a certain degree of discomfort for the patient. For this reason, the investigators believe this study is necessary, as it could demonstrate a new adjuvant therapy that reduces pain and anxiety and improves the overall experience of the patient, in addition to being music, a low-cost tool with no risks for patient safety.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location status: Recruiting

Location contact

Mireia

CONTACT

21660

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 18 years.
  • Clinical and radiological diagnosis of a fracture of the distal end of a closed radius that has an indication for closed reduction.

Exclusion criteria

  • Diagnosis of other concomitant fractures.
  • Allergy to local anesthetics.
  • Significant hearing impairment and/or use of hearing aids.
  • Patients whose comorbidities prevent correct participation in the procedure (such as cognitive impairment, diagnosis of psychiatric diseases, patients under the influence of drugs...).

Treatment and study plan

No Music

Device

No listening to music while intervention is carried out

Music

Device

Listening to music while intervention is carried out

Primary outcomes

  1. Change in VAS scale for pain

    Time frame: Will be completed just after the fracture immobilization

    It will be completed after the procedure and the punctuation will go from 0 to 10

  2. Change in Anxiety STAI-6

    Time frame: Done just before and after the pfracture immobilization

    Puntuation between 20 and 80, 50 considered high anxiety level

Secondary outcomes

  1. Cardiac frequency

    Time frame: Will be assessed just before, during and after the fracture immobilization

    Measurement of the cardiac frequency assessed before, during and after fracture immobilization

  2. Blood pressure

    Time frame: Will be assessed just before, during and after the fracture imobilization

    Measurement of the blood pressure will be assessed before, during and after fracture immobilization

  3. Satisfaction after procedure

    Time frame: Just after the immobilization, when patient will be discharged

    1 to 5 scale for satisfaction with the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Enrique Cueva, Doctor

CONTACT

[email protected]

937 23 10 10 ext. 21660

Mireia Viñas, Doctor

CONTACT

[email protected]

937 23 10 10 ext. 21660

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

Music During the Reduction of Distal Radius Fractures as an Adjunctive Therapy for Pain and Anxiety Management: A Randomized Controlled Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 3, 2023
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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